ATOMOXETINE HYDROCHLORIDE capsule

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)

Fáanlegur frá:

Sandoz Inc

INN (Alþjóðlegt nafn):

ATOMOXETINE HYDROCHLORIDE

Samsetning:

ATOMOXETINE HYDROCHLORIDE 10 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Atomoxetine hydrochloride capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine hydrochloride capsules was established in six clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18) and two 10-week trials in adults [see CLINICAL STUDIES (14 ) ]. A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the

Vörulýsing:

Atomoxetine hydrochloride capsules are available as follows: 10 mg, hard gelatin capsules with opaque white cap and body containing white to off white colored powder equivalent to 10 mg of atomoxetine. The cap is printed with ‘SZ’ and the body is printed with ‘518’ in black ink. NDC 0781-2260-31, bottle of 30 capsules NDC 0781-2260-22, bottle of 2000 capsules 18 mg, hard gelatin capsules with gold cap and opaque white body containing white to off white colored powder equivalent to 18 mg of atomoxetine. The cap is printed with ‘SZ’ and the body is printed with ‘519’ in black ink. NDC 0781-2261-31, bottle of 30 capsules NDC 0781-2261-22, bottle of 2000 capsules 25 mg, hard gelatin capsules with opaque blue cap and opaque white body containing white to off white colored powder equivalent to 25 mg of atomoxetine. The cap is printed with ‘SZ’ and the body is printed with ‘520’ in black ink. NDC 0781-2262-31, bottle of 30 capsules NDC 0781-2262-22, bottle of 2000 capsules 40 mg, hard gelatin capsules with opaque blue cap and body containing white to off white colored powder equivalent to 40 mg of atomoxetine. The cap is printed with ‘SZ’ and the body is printed with ‘521’ in black ink. NDC 0781-2263-31, bottle of 30 capsules NDC 0781-2263-22, bottle of 2000 capsules 60 mg, hard gelatin capsules with opaque blue cap and gold body containing white to off white colored powder equivalent to 60 mg of atomoxetine. The cap is printed with ‘SZ’ and the body is printed with ‘522’ in black ink. NDC 0781-2264-31, bottle of 30 capsules NDC 0781-2264-22, bottle of 2000 capsules 80 mg, hard gelatin capsules with opaque brown cap and opaque white body containing white to off white colored powder equivalent to 80 mg of atomoxetine. The cap is printed with ‘SZ’ and the body is printed with ‘523’ in black ink. NDC 0781-2265-31, bottle of 30 capsules NDC 0781-2265-22, bottle of 2000 capsules 100 mg, hard gelatin capsules with opaque brown cap and body containing white to off white colored powder equivalent to 100 mg of atomoxetine. The cap is printed with ‘SZ’ and the body is printed with ‘524’ in black ink. NDC 0781-2266-31, bottle of 30 capsules NDC 0781-2266-22, bottle of 2000 capsules Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ATOMOXETINE HYDROCHLORIDE- ATOMOXETINE HYDROCHLORIDE CAPSULE
SANDOZ INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATOMOXETINE HYDROCHLORIDE CAPSULES SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATOMOXETINE
HYDROCHLORIDE CAPSULES INITIAL U.S.
APPROVAL: 2002
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL IDEATION IN CHILDREN OR ADOLESCENTS (5.1)
NO SUICIDES OCCURRED IN CLINICAL TRIALS (5.1)
PATIENTS STARTED ON THERAPY SHOULD BE MONITORED CLOSELY (5.1)
RECENT MAJOR CHANGES
Warning and Precautions, Severe Liver Injury (5.2) 06/2009
Warning and Precautions, Allergic Events (5.8) 07/2010
INDICATIONS AND USAGE
Atomoxetine hydrochloride is a selective norepinephrine reuptake
inhibitor indicated for the treatment of Attention-
Deficit/Hyperactivity Disorder (ADHD). (1.1) (1)
DOSAGE AND ADMINISTRATION
Initial, Target and Maximum Daily Dose (2.1) (2)
(Acute and Maintenance/Extended Treatment) (2)
BODY WEIGHT
INITIAL DAILY DOSE
TARGET TOTAL DAILY DOSE
MAXIMUM TOTAL DAILY DOSE
Children and adolescents up
to 70 kg
0.5 mg/kg
1.2 mg/kg
1.4 mg/kg
Children and adolescents over
70 kg and adults
40 mg
80 mg
100 mg
Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, and
in patients known to be CYP2D6 poor
metabolizers (PMs). (2.4, 12.3) (2)
DOSAGE FORMS AND STRENGTHS
Each capsule contains atomoxetine hydrochloride equivalent to 10, 18,
25, 40, 60, 80, or 100 mg of atomoxetine. (3, 11, 16)
(3)
CONTRAINDICATIONS
Hypersensitivity to atomoxetine or other constituents of product.
(4.1)
Atomoxetine hydrochloride use within 2 weeks after discontinuing MAOI
or other drugs that affect brain monoamine
concentrations. (4.2, 7.1)
Narrow Angle Glaucoma. (4.3)
WARNINGS AND PRECAUTIONS
Suicidal Ideation - Monitor for suicidality, clinical worsening, and
unusual changes in behavior. (5.1)
Severe Liver Injury - Should be discontinued and not restarted